News & Analysis as of

Controlled Substances Pharmaceutical Industry

Kelley Drye & Warren LLP

Highlights from the 2025 NAAG Presidential Summit

In early August, the National Association of Attorneys General, led by its 2025 President, New Hampshire Attorney General John Formella, hosted the Presidential Initiative Summit in Portsmouth, New Hampshire. General...more

Ropes & Gray LLP

HALT Fentanyl Act: Unpacking its Significant Reforms for Controlled Substance Research

Ropes & Gray LLP on

On July 16, 2025, President Trump signed the Halt All Lethal Trafficking of Fentanyl (“HALT Fentanyl”) Act into law. The law permanently reclassifies “fentanyl-related substances” into Schedule I of the Controlled Substances...more

Morgan Lewis

Several Planned DEA Actions Remain Pending as New DEA Administrator Awaits Confirmation

Morgan Lewis on

The US Senate held a confirmation hearing on April 30, 2025 for Terrance C. Cole, the president’s nominee for the administrator of the Drug Enforcement Administration. Although Administrator-nominee Cole’s policy priorities...more

ArentFox Schiff

Investigations Newsletter: Walgreens to Pay $300 Million to Settle DOJ Claims Over Invalid Opioid Prescriptions

ArentFox Schiff on

Walgreens to Pay $300 Million to Settle DOJ Claims Over Invalid Opioid Prescriptions - Walgreens Boots Alliance has agreed to pay more than $300 million to resolve allegations brought by the US Department of Justice (DOJ)...more

McDermott Will & Schulte

Healthcare Regulatory Check-Up Newsletter | January 2025 Recap

This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for January 2025. This month features long-awaited proposed and final rules regarding the Health Insurance Portability and Accountability...more

Holland & Knight LLP

Holland & Knight Health Dose: February 19, 2025

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Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector....more

Rivkin Radler LLP

DEA Announces New Telemedicine Rules Expanding Access to Controlled Substances

Rivkin Radler LLP on

On January 16, the U.S. Drug Enforcement Administration (DEA) announced three new telemedicine rules that extend prescribing flexibilities for controlled substances, following the expiration of temporary flexibilities granted...more

Jones Day

DEA Releases Rules on Telemedicine Prescribing of Controlled Substances, Proposes Special Registrations

Jones Day on

The Drug Enforcement Administration ("DEA") announced three new regulations related to the prescription of controlled substances resulting from a telemedicine encounter, including the long-anticipated Proposed Rule on Special...more

Morgan Lewis

DEA Proposed Telemedicine Prescribing Rule Could Burden Hospice Physicians and Hospice Operations

Morgan Lewis on

Signaling a possible future approach to regulating Schedule II-V prescribing via telemedicine in lieu of in-person examinations, on January 17 the DEA issued a notice of proposed rulemaking regarding its next iteration of...more

DLA Piper

DEA and HHS Propose Telemedicine Special Registration and Finalize Buprenorphine Telemedicine Prescribing Rules

DLA Piper on

On January 17, 2025, the US Drug Enforcement Administration (DEA) and the US Department of Health and Human Services (HHS) published two rules regarding telemedicine prescribing of controlled substances: a proposed rule...more

Bradley Arant Boult Cummings LLP

How Will the Cannabis World Look When Marijuana Is Rescheduled?

A few weeks ago, someone at a holiday party asked “Whitt, why doesn’t Budding Trends take on the weighty legal issues of the day and instead resort to cheap pop culture references and puns?” I thought about responding with a...more

Bennett Jones LLP

Supreme Court of Canada Endorses Comity in Class Proceedings in Response to the Opioid Epidemic

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A national class action on behalf of multiple Canadian governments to recover opioid epidemic healthcare costs simplifies the aggregation, prosecution, and determination of claims that span geographic boundaries. That is what...more

Polsinelli

Santa is Bringing Long-Awaited Regulatory Changes to Massachusetts Pharmacy Licensure

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After almost a decade of waiting, Massachusetts has announced that it will open its licensing process for non-resident pharmacies. Yesterday, the Massachusetts Board of Registration in Pharmacy published a memo announcing...more

Quarles & Brady LLP

Are You Ready for Massachusetts Non-Resident Pharmacy Licensure?

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On November 19, 2024, the Massachusetts Board of Registration in Pharmacy (the “Board”) published several memoranda that described the impending non-resident pharmacy licensure requirements and the anticipated timeline for...more

Ropes & Gray LLP

[Podcast] Controlling Opinions: Navigating DEA Diversion Investigations

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On this episode of Ropes & Gray’s podcast series Controlling Opinions, Josh Oyster, a partner in the life sciences regulatory and compliance practice group, is joined by colleagues Andrew O’Connor, a litigation and...more

McDermott+

Virtual Care Policy Update: What to Expect in Lame Duck

McDermott+ on

The Consolidated Appropriations Act (CAA), 2023 (Public Law 117-328), signed into law on December 29, 2022, extended certain key virtual care flexibilities instituted during the COVID-19 public health emergency (PHE) through...more

McDermott+

Pending DEA Extension on Prescription of Controlled Substances via Telemedicine

McDermott+ on

A new rule posted on the Office of Management and Budget (OMB) registry suggests that the Drug Enforcement Administration (DEA) is planning an additional extension of COVID-19 flexibilities for telemedicine prescribing of...more

Bass, Berry & Sims PLC

Hospital Faces Serious Patient Lawsuits Stemming from Drug Diversion

At least two private civil lawsuits have been filed against Asante Rogue Regional Medical Center in Medford, Oregon, in connection with a fentanyl diversion and related indictment of a former nurse. A wrongful death suit...more

Bradley Arant Boult Cummings LLP

MDMA DOA at FDA Advisory Committee

Avid readers know we have speculated that the legalization of psychedelics as a prescription medicine was “closer than ever.” Unfortunately, for proponents of the legalization of psychedelics like MDMA, progress is rarely a...more

McDermott+

Exploring the Virtual Care Policy Landscape One Year Post-PHE

McDermott+ on

May 11, 2024, marked one year since the end of the COVID-19 public health emergency (PHE), and not much has changed in Medicare telehealth policy. We are still operating under temporary waivers and flexibilities and, as a...more

Morgan Lewis - As Prescribed

Taking a Trip into the Future of Psychedelics

The development of psychedelic drugs for medicinal uses has substantially expanded since 2020, as evidenced by an exponential growth in Drug Enforcement Administration (DEA) production quotas for both psilocybin and psilocin....more

Troutman Pepper Locke

Reassessing Oregon’s Drug Policy: A Shift Toward Recriminalization

Troutman Pepper Locke on

In the grand experiment of American democracy, it is often said that states serve as laboratories, testing policies that challenge the status quo without risking the stability of the whole. Oregon, known in recent years for...more

Cozen O'Connor

CVS Settles with Alaska AG for $10 Million over Opioid Allegations

Cozen O'Connor on

Alaska AG Treg Taylor has reached a settlement with CVS Pharmacy, Inc. to resolve allegations that the company violated Alaska’s Unfair Trade Practices and Consumer Protection Act by allegedly dispensing opioid-containing...more

Faegre Drinker Biddle & Reath LLP

Remote Prescribing of Controlled Substances via Telehealth: Stakeholders Urge DEA to Address Geographic Red Flag for Pharmacists

Due to convenience and effectiveness, patients are increasingly seeking care via telehealth, including for conditions that require treatment with medication. During the pandemic, patients gained access to telehealth for...more

Quarles & Brady LLP

It's (Apparently) Never Too Late Part II: DEA & Morris & Dickson Settle

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This week, DEA announced it has entered into a settlement agreement with Morris & Dickson Co., LLC (“Morris & Dickson”), resolving the protracted dispute born out of a May 2, 2018 Order to Show Cause (“OTSC”) and Immediate...more

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